Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Dapagliflozin
Drug ID BADD_D00578
Description Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor indicated for managing diabetes mellitus type 2.[A6757] When combined with diet and exercise in adults, dapagliflozin helps to improve glycemic control by inhibiting glucose resorption in the proximal tubule of the nephron and causing glycosuria.[A6757] Dapagliflozin was approved by the FDA on Jan 08, 2014.[L6034]
Indications and Usage Dapagliflozin is indicated to improve glycemic control in adult patients with type 2 diabetes mellitus along with diet and exercise[Label,A6757,A6758].
Marketing Status approved
ATC Code A10BK01
DrugBank ID DB06292
KEGG ID D08897
MeSH ID C529054
PubChem ID 9887712
TTD Drug ID D01TNW
NDC Product Code 0310-8210; 12783-1428; 59651-135; 66064-1029; 69037-0027; 50090-3482; 12783-1427; 17228-6205; 59285-012; 75945-600; 55154-6933; 54921-620; 55111-987; 66529-0003; 0310-6205; 50193-1427; 14501-0028; 0310-6210; 66039-933; 54921-621; 65727-073; 55154-6932; 0310-8205; 17228-6210; 50090-3481
UNII 1ULL0QJ8UC
Synonyms dapagliflozin | (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6- (hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol | Farxiga | Forxiga | 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol | BMS 512148 | BMS512148 | BMS-512148
Chemical Information
Molecular Formula C21H25ClO6
CAS Registry Number 461432-26-8
SMILES CCOC1=CC=C(C=C1)CC2=C(C=CC(=C2)C3C(C(C(C(O3)CO)O)O)O)Cl
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Pancreatitis acute07.18.01.0020.001536%Not Available
Pemphigoid10.04.02.002; 23.03.01.0040.000439%Not Available
Pemphigus23.03.01.005; 10.04.02.0030.000219%Not Available
Penis disorder21.12.01.0010.002347%Not Available
Peripheral circulatory failure24.06.02.0200.000219%Not Available
Peripheral coldness23.06.04.008; 24.04.03.006; 08.01.09.0100.000483%Not Available
Peripheral ischaemia24.04.03.0020.000921%
Pollakiuria20.02.02.0070.010244%
Polycythaemia01.07.01.0010.001821%Not Available
Polydipsia14.05.02.001; 05.03.03.0020.000856%Not Available
Polyuria20.02.03.0020.002106%Not Available
Proctalgia07.03.02.0010.000483%
Prostatic disorder21.04.01.0010.000483%Not Available
Prostatitis21.09.01.0010.000329%Not Available
Proteinuria20.02.01.0110.002830%
Pruritus genital23.03.12.008; 21.10.01.0020.002084%Not Available
Rash23.03.13.001--Not Available
Rash maculo-papular23.03.13.0040.000702%
Renal cyst16.27.01.001; 20.01.04.0010.000702%Not Available
Renal disorder20.01.02.0020.003269%Not Available
Renal failure20.01.03.0050.004541%Not Available
Renal pain20.02.03.0030.001228%Not Available
Renal tubular necrosis20.01.07.0030.000329%Not Available
Rhabdomyolysis15.05.05.0020.000768%
Skin discolouration23.03.03.005--Not Available
Skin disorder23.03.03.007--Not Available
Skin fissures23.03.03.0080.000702%Not Available
Skin necrosis23.03.03.0110.000329%Not Available
Skin ulcer24.04.03.007; 23.07.03.0030.002654%
Sudden death08.04.01.003; 02.03.04.0130.000219%
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